Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
Europe – New Notified Body Designated Under EU MDR
RISE Medical Notified Body AB
Sweden
Europe – Normes Harmonisées 2024/817
La décision d’éxecution (EU) 2024/817 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives à la stérilisation des produits de...
Europe – Normes Harmonisées 2024/815
La décision d’exécution (EU) 2024/815 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives aux gants médicaux non réutilisables, à...
UK – New action to tackle ethnic and other biases in medical devices
Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of...
Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux...
En décembre 2023, LNE-GMED UK, filiale GMED du groupe LNE a été accrédité par UKAS (United Kingdom Accreditation Service) au titre de la norme...
Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech...
Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby...
Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...
Europe – Experts outline challenges of combination products in Europe
Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director...
